Results from Novan’s Phase 2b clinical trial to evaluate the efficacy and safety of topical nitric oxide-releasing product candidate SB204 gel for the treatment of acne vulgaris will be presented at the 35th Anniversary Fall Clinical Dermatology Conference in Las Vegas. The presentation will include results of efficacy assessments and additional data regarding the tolerability of SB204 throughout the 12-week trial. 

“In more than 30 years of experience as a dermatologist, I have seen firsthand how the tolerability of a topical acne product drives patient compliance,” said M. Joyce Rico, MD, Chief Medical Officer of Novan. “The safety and tolerability profile observed in the Phase 2b clinical trial with SB204 was excellent. Of all five tolerability assessments, the burning/stinging and scaling categories reflected the most notable difference between active and vehicle. Patients treated with SB204 rarely developed moderate (<3%) or severe (1%) burning/stinging at any point during treatment, while the incidence of moderate scaling never exceeded 1%.” 

Novan’s two, identically designed Phase 3 pivotal clinical trials for SB204 were fully enrolled as of September. Novan expects to report top-line results from these Phase 3 trials in the first quarter of 2017.